- Dr. Dhole's Sushanti Homeopathy Clinic - claims homeopathy medicine which is selected as Genus Epidemicus is given to healthy people to prevent Coronavirus
- Honey Colony LLC - sell a chealated silver product with claims as a prevention from coronavirus.
- Antroids.com and Foxroids.com - offers lopinavir + ritonavir, marketed as “Lopimune 200mg/50mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of lopinavir + ritonavir on the market in the U.S., there are no approved drug applications offered by either company In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19
- Hopewell Essential Oils - Claims that using essential oils to make breathing easier with Coronavirus related pneumonia.
- Santiste Labs LLC - Created a transdermal patch with that claims to boost your immune system and provide antiviral support all day,
- Prefense LLC - marketing and online sales for hand sanitizers with claims that it works against COVID-19 and that the sanitizer lasts all day.
Dr. Dhole's Sushanti Homeopathy Clinic
Claims
“Homeopathy Treatments Available For: . . . Coronavirus (2019-nCov) Prevention” [from your website at www.homeopathyhelps.com]
“Role of Homeopathy in current Coronavirus disease (COVID-19) pandemic: . . . Epidemics and pandemics can be kept under control by boosting people's immune system using well selected ‘Homeopathic Genus Epidemicus.’ The homeopathy medicine which is selected as Genus Epidemicus is given to healthy people in that particular region to prevent the illness. In the past homeopathy has helped in pandemics many times in different parts of the world.” [from your website at www.homeopathyhelps.com]
FDA Issue
It is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/honey-colony-llc-607346-05042020
Honey Colony LLC
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/honey-colony-llc-607346-05042020
Honey Colony LLC
Claims
The Best Coronavirus Treatment is Prevention . . .
There may be natural ways to take control and prevent viral infections from taking hold, coronavirus included. . . .
If you want a direct antiviral effect . . . chelated silver . . . can target a wide range of viruses through several mechanisms. It is best to combine this with immune-boosting foods or supplements…. The aim of these supplements is to boost the immune system and provide some direct antiviral support:
Vitamin C 3,000 milligrams (or more) daily, in divided doses. Clinical trials of vitamin C for coronavirus patients are already underway in China. Previous research on 252 students found that 85 percent experienced relief from respiratory infections if they took high-dose vitamin C. . . .
Magnesium: 400 mg daily . . .
The above antiviral protocol can go a long way in protecting yourself against both this epidemic disease and other common infections like influenza. . . .
FDA Issue
It is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the products identified above. Thus, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/antroidscom-606116-04222020
The Best Coronavirus Treatment is Prevention . . .
There may be natural ways to take control and prevent viral infections from taking hold, coronavirus included. . . .
If you want a direct antiviral effect . . . chelated silver . . . can target a wide range of viruses through several mechanisms. It is best to combine this with immune-boosting foods or supplements…. The aim of these supplements is to boost the immune system and provide some direct antiviral support:
Vitamin C 3,000 milligrams (or more) daily, in divided doses. Clinical trials of vitamin C for coronavirus patients are already underway in China. Previous research on 252 students found that 85 percent experienced relief from respiratory infections if they took high-dose vitamin C. . . .
Magnesium: 400 mg daily . . .
The above antiviral protocol can go a long way in protecting yourself against both this epidemic disease and other common infections like influenza. . . .
FDA Issue
It is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the products identified above. Thus, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/antroidscom-606116-04222020
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/foxroidscom-606131-04222020
Antroids.com and Foxroids.com
www.antroids.com [as well as Foxroids.com] offers lopinavir + ritonavir, marketed as “Lopimune 200mg/50mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of lopinavir + ritonavir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Lopimune 200mg/50mg” offered by www.antroids.com. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.[4]
In addition, www.antroids.com offers ritonavir, marketed as “Ritomune 100 mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of ritonavir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Ritomune 100 mg” offered by www.antroids.com. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
www.foxroids.com and antroids also offers oseltamivir, marketed as “Fluvir 75 mg” and “Antiflu 75mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of oseltamivir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Fluvir 75 mg” or “Antiflu 75mg” products offered by www.foxroids.com. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
Both offer ers ritonavir, marketed as “Ritomune 100 mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of ritonavir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Ritomune 100 mg” offered by www.foxroids.com. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hopewell-essential-oils-607088-04272020
Hopewell Essential Oils
Antroids.com and Foxroids.com
www.antroids.com [as well as Foxroids.com] offers lopinavir + ritonavir, marketed as “Lopimune 200mg/50mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of lopinavir + ritonavir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Lopimune 200mg/50mg” offered by www.antroids.com. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.[4]
In addition, www.antroids.com offers ritonavir, marketed as “Ritomune 100 mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of ritonavir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Ritomune 100 mg” offered by www.antroids.com. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
www.foxroids.com and antroids also offers oseltamivir, marketed as “Fluvir 75 mg” and “Antiflu 75mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of oseltamivir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Fluvir 75 mg” or “Antiflu 75mg” products offered by www.foxroids.com. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
Both offer ers ritonavir, marketed as “Ritomune 100 mg,” under the heading “Coronavirus Treatment.” While there are FDA-approved versions of ritonavir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Ritomune 100 mg” offered by www.foxroids.com. In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hopewell-essential-oils-607088-04272020
Hopewell Essential Oils
Claims
“The Coronavirus presents pneumonia-like symptoms, making it difficult to breathe. For respiratory issues, my favorite blends are Lung Support [hyperlink[8]] and Respiratory Relief [hyperlink[9]]. For children or pregnant women, I’d consider Breathe Easy [hyperlink[10]] and/or Breathe Happy [hyperlink[11]]. If I became ill with a respiratory virus, I’d diffuse one of these, but if I didn’t have a diffuser, I’d get an inexpensive surgical or dust mask. . . and put a couple of drops of essential oil onto the mask. I’d wear it . . .to inhale the essential oils. . . Inhaling essential oils is an excellent way to get the oils into the bloodstream, thus I’d figure out some way for those ill to inhale them frequently. . .
FDA Issue
it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the products identified above. Thus, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/santiste-labs-llc-607227-04272020
Santiste Labs LLC
Claims
“The Coronavirus presents pneumonia-like symptoms, making it difficult to breathe. For respiratory issues, my favorite blends are Lung Support [hyperlink[8]] and Respiratory Relief [hyperlink[9]]. For children or pregnant women, I’d consider Breathe Easy [hyperlink[10]] and/or Breathe Happy [hyperlink[11]]. If I became ill with a respiratory virus, I’d diffuse one of these, but if I didn’t have a diffuser, I’d get an inexpensive surgical or dust mask. . . and put a couple of drops of essential oil onto the mask. I’d wear it . . .to inhale the essential oils. . . Inhaling essential oils is an excellent way to get the oils into the bloodstream, thus I’d figure out some way for those ill to inhale them frequently. . .
FDA Issue
it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the products identified above. Thus, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/santiste-labs-llc-607227-04272020
Santiste Labs LLC
Claims
“Santiste Labs, the science driven leader in transdermal delivery has just announced the release of the DEFEND Patch in response to the global pandemic and acute health crisis of COVID-19. The company . . . created a transdermal patch that can boost your immune system and provide antiviral support all day, using all-natural ingredients. Their patent-pending composition of botanical oils uses TD-CUBED technology to provide precise, sustained release through the skin over 3 days.” [from your website https://defendpatch.com/pages/about-defend]
“DEFEND PATCH . . . DEFEND IN THE NEWS . . . Scientists are looking into many approaches to combating a corona virus epidemic. One of the products that offers possible resistance to the novel corona virus is a transdermal patch developed by Santiste Labs LLC . . . The patches are designed to deliver CBD, or other natural substances known to have antiviral properties . . . The novel corona virus (COVID-19), first noted in December in China, is moving close to home.” [from your website https://defendpatch.com/pages/news-and-media]
FDA Issue
Is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prefense-llc-605488-04232020
Prefense LLC - . Among the claims
“Coronavirus now a global emergency! . . . Be safe out there – the best defense is Prefense hand sanitizer – up to 24 hour protection from one application – it works when it dries!”
"Prefense™ is a revolutionary, non-toxic, high-level hospital-grade foam hand sanitizer that continually protects against bacteria, fungi and viruses including all strains of staph, strep, E.coli, drug resistant MRSA, Wuhan COVID-19 Coronavirus and more with just one application daily...and is safe for children!”
Your Prefense Hand Sanitizers do not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rub proposed rule and the 2015 Health Care Antiseptic proposed rule, nor any other TFM or final rule, and do not meet the conditions under section 505G(a)(3) of the FD&C Act, as added by the CARES Act, for marketing without an approved application under section 505. First, we note that your products are labeled with Amosilq (benzalkonium chloride/silica complex) as the active ingredient. Amosilq was not a proposed active ingredient in the rulemaking for topical antiseptic drug products. Second, even if benzalkonium chloride were considered the active ingredient in Prefense Hand Sanitizers, the labeling for your products does not conform to the relevant labeling conditions in the 1994 TFM and its subsequent amendments.[5]
Specifically, your labeling claims suggesting that Prefense Hand Sanitizers are effective in preventing infection or disease from specific pathogens such as “staph, strep, E.coli, drug resistant MRSA, Wuhan COVID-19 Coronavirus and more” go beyond merely describing the general intended use of a topical antiseptic as set forth in the 1994 TFM. Additionally, your labeling claims suggesting that Prefense Hand Sanitizers provide up to 24 hours of efficacy against serious-disease related pathogens including the novel coronavirus that causes COVID-19 do not conform to the 1994 TFM or any of the amendments to the TFM discussed above. Time-specific extended efficacy claims, especially when related to serious disease-related pathogens, may lead to a false sense of security for the general public and result in infrequent hand washing or the substitution of these products for protective gloves and clothing, which are the principal methods for protecting against the spread of diseases caused by pathogenic microorganisms. As such, these products may give users the false impression that they need not rigorously adhere to interventions such as social distancing and exercising good hygienic practices that have been demonstrated to curb the spread of COVID-19. Users who do not follow these interventions are at increased risk for contracting COVID-19 and for spreading disease if they have been exposed to the virus, thereby prolonging the pandemic and increasing its associated morbidity and mortality.
We are unaware of any adequate and well-controlled clinical studies in the published literature that support a determination that Prefense Hand Sanitizers are GRASE for the above-described intended uses, including the time-specific extended efficacy claims. Accordingly, Prefense Hand Sanitizers are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C §§ 355(a) and 331(d). We note that they also do not conform to any temporary policy FDA has implemented for alcohol-based hand sanitizer products during the public health emergency.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prefense-llc-605488-04232020
“DEFEND PATCH . . . DEFEND IN THE NEWS . . . Scientists are looking into many approaches to combating a corona virus epidemic. One of the products that offers possible resistance to the novel corona virus is a transdermal patch developed by Santiste Labs LLC . . . The patches are designed to deliver CBD, or other natural substances known to have antiviral properties . . . The novel corona virus (COVID-19), first noted in December in China, is moving close to home.” [from your website https://defendpatch.com/pages/news-and-media]
FDA Issue
Is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prefense-llc-605488-04232020
Prefense LLC - . Among the claims
“Coronavirus now a global emergency! . . . Be safe out there – the best defense is Prefense hand sanitizer – up to 24 hour protection from one application – it works when it dries!”
"Prefense™ is a revolutionary, non-toxic, high-level hospital-grade foam hand sanitizer that continually protects against bacteria, fungi and viruses including all strains of staph, strep, E.coli, drug resistant MRSA, Wuhan COVID-19 Coronavirus and more with just one application daily...and is safe for children!”
Your Prefense Hand Sanitizers do not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rub proposed rule and the 2015 Health Care Antiseptic proposed rule, nor any other TFM or final rule, and do not meet the conditions under section 505G(a)(3) of the FD&C Act, as added by the CARES Act, for marketing without an approved application under section 505. First, we note that your products are labeled with Amosilq (benzalkonium chloride/silica complex) as the active ingredient. Amosilq was not a proposed active ingredient in the rulemaking for topical antiseptic drug products. Second, even if benzalkonium chloride were considered the active ingredient in Prefense Hand Sanitizers, the labeling for your products does not conform to the relevant labeling conditions in the 1994 TFM and its subsequent amendments.[5]
Specifically, your labeling claims suggesting that Prefense Hand Sanitizers are effective in preventing infection or disease from specific pathogens such as “staph, strep, E.coli, drug resistant MRSA, Wuhan COVID-19 Coronavirus and more” go beyond merely describing the general intended use of a topical antiseptic as set forth in the 1994 TFM. Additionally, your labeling claims suggesting that Prefense Hand Sanitizers provide up to 24 hours of efficacy against serious-disease related pathogens including the novel coronavirus that causes COVID-19 do not conform to the 1994 TFM or any of the amendments to the TFM discussed above. Time-specific extended efficacy claims, especially when related to serious disease-related pathogens, may lead to a false sense of security for the general public and result in infrequent hand washing or the substitution of these products for protective gloves and clothing, which are the principal methods for protecting against the spread of diseases caused by pathogenic microorganisms. As such, these products may give users the false impression that they need not rigorously adhere to interventions such as social distancing and exercising good hygienic practices that have been demonstrated to curb the spread of COVID-19. Users who do not follow these interventions are at increased risk for contracting COVID-19 and for spreading disease if they have been exposed to the virus, thereby prolonging the pandemic and increasing its associated morbidity and mortality.
We are unaware of any adequate and well-controlled clinical studies in the published literature that support a determination that Prefense Hand Sanitizers are GRASE for the above-described intended uses, including the time-specific extended efficacy claims. Accordingly, Prefense Hand Sanitizers are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C §§ 355(a) and 331(d). We note that they also do not conform to any temporary policy FDA has implemented for alcohol-based hand sanitizer products during the public health emergency.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prefense-llc-605488-04232020
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